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MAY 2020

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in May 2020.

Key Lessons Learned during the First Month of the COVID-19 Pandemic Response

As we are well-rooted in the response phase of the COVID-19 pandemic, we have seen a flurry of sponsors looking through their pipelines to find either approved or investigational products that could help treat, diagnose or prevent COVID-19. As such, Veristat spent the first four weeks of the pandemic response supporting five clinical research programs for COVID-19 vaccines and treatments. And, we are rapidly fielding daily requests for more programs.

April 2020

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in April 2020.

March 2020

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. Below are the relevant links to updates provided in March 2020.

MHRA Guidance On Clinical Trial Conduct During COVID-19 Pandemic

FDA UPDATES - For Sponsors with Products Intended to Treat Indications Other than COVID-19

In this unique time, with many health authorities, governments and pharmaceutical companies focused on the global pandemic and how to prevent, diagnose and treat COVID-19, it is important to remember the number of therapies currently in development or already approved for the multitude of other diseases affecting people worldwide. FDA has issued several press releases and guidance that affect Sponsors running or planning clinical studies, those planning marketing applications and those with products already on the market. We summarize here valuable information that is important for drug and biologic companies to be aware of as they continue to try to make these therapies available to patients.